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AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF… recallZ-1179-2025 · Hollister Incorporated · initiated Dec 23, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Hollister Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

FDA root cause category: Process change control

What the company is doing

Hollister issued an URGENT - MEDICAL DEVICE RECALL notice to its consignees on 12/23/2024 via FedEx and email. The notice explained the reason for the recall and potential risk and instructed customers to quarantine affected inventory, discard the product per their local procedures for product destruction, and Please complete and return the response form attached as soon as possible, even if you do not have affected product in your possession and send to [email protected]. For product credit requests: If you are a direct customer of Hollister, contact Hollister Incorporated Customer Service for product credit at: 1-800-323-4060 (prompt #1). If you purchase product from a distributor, please contact your distributor for product credit. Hollister has posted this recall on their website with the link to the page.

Recall details

Recall number
Z-1179-2025
Status
Open, Classified
Initiated by the company
Dec 23, 2024
Posted by the FDA
Feb 19, 2025
Recalling firm
Hollister Incorporated
Quantity
45 box / 540 eaches
Product code
CBH
Distribution
Worldwide distribution - US Nationwide and the country of Canada.

Product description

AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,

Code information (models, lots, serial numbers)

UDI/DI 00610075095834, Lot Numbers: 4L172, 4L182

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96181).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page